Public Protocols

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Effective immediately on 02/07/18, pre-registration (Step 0) and registration (Step 1) to A071401 have been temporarily suspended. The manufacturer of the investigational agent vismodegib has discontinued provision to new patients on A071401. Therefore, effectively immediately, the SMO/PTCH1 Grade I and SMO/PTCH1 Grade II/III cohorts on A071401 are closed to new patient registration (Step 1).

The protocol allows designated private sector laboratories to refer patients to the study based on genetic testing performed independent of MATCH. This is limited to genetic testing ordered for patients at approved MATCH trial sites. Approved genetic testing laboratories and their date of inclusion in the outside assay process are:

CARIS Life Sciences – 07/02/18

CellNetix Pathology and Laboratories – 02/13/19

Foundation Medicine – 07/02/18

GenPath BioReference Laboratories – 08/03/18

The Jackson Laboratory – 01/10/19

NeoGenomics Laboratories – 07/02/18

OmniSeq Laboratories – 07/16/18

PathGroup – 10/29/18

Quest Diagnostics Inc. – 05/20/19

Strata Oncology – 08/03/18

Tempus Laboratories – 07/16/18

The Biopsy consent form for this study is available upon request. Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.

Due to concerns regarding the spread of the novel coronavirus and the impact it is having on hospitals, clinics, physician offices, and patients’ ability to travel, the study will be temporarily suspended to new patient accrual, effective immediately, March 23, 2020.

The protocol allows designated private sector laboratories to refer patients to the study based on genetic testing performed independent of MATCH. This is limited to genetic testing ordered for patients at approved MATCH trial sites. Approved genetic testing laboratories and their date of inclusion in the outside assay process are:

CARIS Life Sciences – 07/02/18

CellNetix Pathology and Laboratories – 02/13/19

Foundation Medicine – 07/02/18

GenPath BioReference Laboratories – 08/03/18

The Jackson Laboratory – 01/10/19

NeoGenomics Laboratories – 07/02/18

OmniSeq Laboratories – 07/16/18

PathGroup – 10/29/18

Quest Diagnostics Inc. – 05/20/19

Strata Oncology – 08/03/18

Tempus Laboratories – 07/16/18

The Biopsy consent form for this study is available upon request. Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.

The accrual goal for the Behaviorial and Health Outcomes (BAHO) Quality of Life component in the B-51 trial has been met. Therefore, effective August 6th, 2018, accrual will be closed to the QoL component. The B-51 trial remains open to accrual.

A Phase II Trial Assessing the Accuracy of Tumor Bed Biopsies in Predicting Pathologic Response in Patients with Clinical/Radiologic Complete Response after Neoadjuvant Chemotherapy in Order to Explore the Feasibility of Breast Conserving Treatment without Surgery

Due to concerns regarding the spread of the novel coronavirus and the impact it is having on hospitals, clinics, physician offices, and patients’ ability to travel, the study will be temporarily suspended to new patient accrual, effective immediately, March 23, 2020.

The protocol allows designated private sector laboratories to refer patients to the study based on genetic testing performed independent of MATCH. This is limited to genetic testing ordered for patients at approved MATCH trial sites. Approved genetic testing laboratories and their date of inclusion in the outside assay process are:

CARIS Life Sciences – 07/02/18

CellNetix Pathology and Laboratories – 02/13/19

Foundation Medicine – 07/02/18

GenPath BioReference Laboratories – 08/03/18

The Jackson Laboratory – 01/10/19

NeoGenomics Laboratories – 07/02/18

OmniSeq Laboratories – 07/16/18

PathGroup – 10/29/18

Quest Diagnostics Inc. – 05/20/19

Strata Oncology – 08/03/18

Tempus Laboratories – 07/16/18

The Biopsy consent form for this study is available upon request. Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.

A Randomized Trial of the Altering Intake, Managing Symptoms Intervention for Bowel Dysfunction in Rectal Cancer Survivors Compared to a Healthy Living Education Control: A Feasibility and Preliminary Efficacy Study (AIMS-RC)

The protocol allows designated private sector laboratories to refer patients to the study based on genetic testing performed independent of MATCH. This is limited to genetic testing ordered for patients at approved MATCH trial sites. Approved genetic testing laboratories and their date of inclusion in the outside assay process are:

CARIS Life Sciences – 07/02/18

CellNetix Pathology and Laboratories – 02/13/19

Foundation Medicine – 07/02/18

GenPath BioReference Laboratories – 08/03/18

The Jackson Laboratory – 01/10/19

NeoGenomics Laboratories – 07/02/18

OmniSeq Laboratories – 07/16/18

PathGroup – 10/29/18

Quest Diagnostics Inc. – 05/20/19

Strata Oncology – 08/03/18

Tempus Laboratories – 07/16/18

The Biopsy consent form for this study is available upon request. Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.

The protocol allows designated private sector laboratories to refer patients to the study based on genetic testing performed independent of MATCH. This is limited to genetic testing ordered for patients at approved MATCH trial sites. Approved genetic testing laboratories and their date of inclusion in the outside assay process are:

CARIS Life Sciences – 07/02/18

CellNetix Pathology and Laboratories – 02/13/19

Foundation Medicine – 07/02/18

GenPath BioReference Laboratories – 08/03/18

The Jackson Laboratory – 01/10/19

NeoGenomics Laboratories – 07/02/18

OmniSeq Laboratories – 07/16/18

PathGroup – 10/29/18

Quest Diagnostics Inc. – 05/20/19

Strata Oncology – 08/03/18

Tempus Laboratories – 07/16/18

The Biopsy consent form for this study is available upon request. Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.

A Randomized Phase II/III study of the combination of Cediranib and Olaparib compared to Cediranib or Olaparib alone, or Standard of care chemotherapy in women with recurrent platinum-resistant or -refractory ovarian, fallopian tube, or primary peritoneal cancer (COCOS)

This protocol has additional regulatory requirements to be completed prior to registering any patients at your site. Please contact Amber Boerner at 406-969-6067 or aboerner@mtcancer.org for additional information.

Effective immediately on 04/10/19, NRG-GY016 has been temporarily closed to accrual because the study has reached its maximum accrual number of 14 patients for the first stage of the trial. Accrual will be stopped until data is matured and the analysis on the first stage is complete.

This protocol has additional regulatory requirements to be completed prior to registering any patients at your site. Please contact Amber Boerner at 406-969-6067 or aboerner@mtcancer.org for additional information.

NRG Oncology GY018 is temporarily being suspended to accrual in response to the COVID-19 pandemic while we consider options to responsibly continue the trial in the context of the current placebo design. Patients who have already consented and/or entered Step 1 registration will be allowed to proceed. Step 1 registration must be completed for all consented patients by 12 Noon ET, Monday, April 6, 2020.

The protocol allows designated private sector laboratories to refer patients to the study based on genetic testing performed independent of MATCH. This is limited to genetic testing ordered for patients at approved MATCH trial sites. Approved genetic testing laboratories and their date of inclusion in the outside assay process are:

CARIS Life Sciences – 07/02/18

CellNetix Pathology and Laboratories – 02/13/19

Foundation Medicine – 07/02/18

GenPath BioReference Laboratories – 08/03/18

The Jackson Laboratory – 01/10/19

NeoGenomics Laboratories – 07/02/18

OmniSeq Laboratories – 07/16/18

PathGroup – 10/29/18

Quest Diagnostics Inc. – 05/20/19

Strata Oncology – 08/03/18

Tempus Laboratories – 07/16/18

The Biopsy consent form for this study is available upon request. Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.

Randomized Phase II/III Trial of Radiotherapy with Concurrent MEDI4736 (Durvalumab) Vs. Radiotherapy with Concurrent Cetuximab in Patients with Stage III-IVB Head and Neck Cancer with a Contraindication to Cisplatin

Leukemia

A Phase III Trial to Evaluate the Efficacy of the Addition of Inotuzumab Ozogamicin (a Conjugated Anti-CD22 Monoclonal Antibody) to Frontline Therapy in Young Adults (Ages 18-39 Years) with Newly Diagnosed Precursor B-Cell ALL

This protocol has additional regulatory requirements to be completed prior to registering any patients at your site. Please contact Amber Boerner at 406-969-6067 or aboerner@mtcancer.org for additional information.

Suspension to enrollment of new participants and follow-up research sample collection and shipment is lifted effective May 18, 2020, for NHLBI-MDS. Refer to memo dated March 27, 2020, on conducting remote follow-up data for enrolled participants.

Effective immediately,10/25/18, and until further notice, patients will no longer receive nivolumab as part of this study. Additional details are provided in the Investigator Letter and Patient Information Letter.

Effective immediately, 10/22/18, S1612 will be temporarily closed to accrual based on additional review of the safety data. An “Investigator Letter” and “Patient Notification Letter” will be provided in the coming days, pending regulatory approvals.

The protocol allows designated private sector laboratories to refer patients to the study based on genetic testing performed independent of MATCH. This is limited to genetic testing ordered for patients at approved MATCH trial sites. Approved genetic testing laboratories and their date of inclusion in the outside assay process are:

CARIS Life Sciences – 07/02/18

CellNetix Pathology and Laboratories – 02/13/19

Foundation Medicine – 07/02/18

GenPath BioReference Laboratories – 08/03/18

The Jackson Laboratory – 01/10/19

NeoGenomics Laboratories – 07/02/18

OmniSeq Laboratories – 07/16/18

PathGroup – 10/29/18

Quest Diagnostics Inc. – 05/20/19

Strata Oncology – 08/03/18

Tempus Laboratories – 07/16/18

The Biopsy consent form for this study is available upon request. Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.

Treatment consent forms for individual agents for this study are available upon request when a patient at your site is assigned to a study agent. Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consents & for any questions.

LU004 is temporarily closed to accrual effective immediately, April 13, 2020. The study has enrolled 6 patients to Cohort 2 (the standard radiation + MEDI4736 (durvalumab) arm) and will be temporarily closed while the safety of the protocol treatment regimen in both cohorts is monitored.

A Randomized Double-Blind Phase III Study of Ibrutinib During and Following Autologous Stem Cell Transplantation Versus Placebo in Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma of the Activated B-cell Subtype

The protocol allows designated private sector laboratories to refer patients to the study based on genetic testing performed independent of MATCH. This is limited to genetic testing ordered for patients at approved MATCH trial sites. Approved genetic testing laboratories and their date of inclusion in the outside assay process are:

CARIS Life Sciences – 07/02/18

CellNetix Pathology and Laboratories – 02/13/19

Foundation Medicine – 07/02/18

GenPath BioReference Laboratories – 08/03/18

The Jackson Laboratory – 01/10/19

NeoGenomics Laboratories – 07/02/18

OmniSeq Laboratories – 07/16/18

PathGroup – 10/29/18

Quest Diagnostics Inc. – 05/20/19

Strata Oncology – 08/03/18

Tempus Laboratories – 07/16/18

The Biopsy consent form for this study is available upon request. Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.

The protocol allows designated private sector laboratories to refer patients to the study based on genetic testing performed independent of MATCH. This is limited to genetic testing ordered for patients at approved MATCH trial sites. Approved genetic testing laboratories and their date of inclusion in the outside assay process are:

CARIS Life Sciences – 07/02/18

CellNetix Pathology and Laboratories – 02/13/19

Foundation Medicine – 07/02/18

GenPath BioReference Laboratories – 08/03/18

The Jackson Laboratory – 01/10/19

NeoGenomics Laboratories – 07/02/18

OmniSeq Laboratories – 07/16/18

PathGroup – 10/29/18

Quest Diagnostics Inc. – 05/20/19

Strata Oncology – 08/03/18

Tempus Laboratories – 07/16/18

The Biopsy consent form for this study is available upon request. Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.

MATCH Treatment Subprotocol A: Phase II Trial of Afatinib in Patients with Solid Tumors (Other Than Small Cell and Non-Small Cell Lung Cancer) or Lymphomas, That Have Activating Mutations of EGFR and Have Progressed After Standard Treatment

Open to participants with results from one of the designated outside laboratories indicating a “rare variant that is an actionable Mutation of Interest (aMOI) for specific designated rare variant subprotocols. See Appendix XIV of the main protocol for a list of the designated laboratories and applicable subprotocols.

The consent form for this sub-study is available upon request when a patient at your site is assigned to the sub-study. Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.

EAY131 C1 substudy, is reactivated, May 7, 2020, to allow for expanded accrual.

Open to participants with results from one of the designated outside laboratories indicating a “rare variant that is an actionable Mutation of Interest (aMOI) for specific designated rare variant subprotocols. See Appendix XIV of the main protocol for a list of the designated laboratories and applicable subprotocols.

The consent form for this sub-study is available upon request when a patient at your site is assigned to the sub-study. Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.

Open to participants with results from one of the designated outside laboratories indicating a “rare variant that is an actionable Mutation of Interest (aMOI) for specific designated rare variant subprotocols. See Appendix XIV of the main protocol for a list of the designated laboratories and applicable subprotocols.

The consent form for this sub-study is available upon request when a patient at your site is assigned to the sub-study. Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.

Open to participants with results from one of the designated outside laboratories indicating a “rare variant that is an actionable Mutation of Interest (aMOI) for specific designated rare variant subprotocols. See Appendix XIV of the main protocol for a list of the designated laboratories and applicable subprotocols.

The consent form for this sub-study is available upon request when a patient at your site is assigned to the sub-study. Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.

The consent form for this sub-study is available upon request when a patient at your site is assigned to the sub-study. Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.

Open to participants with results from one of the designated outside laboratories indicating a “rare variant that is an actionable Mutation of Interest (aMOI) for specific designated rare variant subprotocols. See Appendix XIV of the main protocol for a list of the designated laboratories and applicable subprotocols.

The consent form for this sub-study is available upon request when a patient at your site is assigned to the sub-study. Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.

Open to participants with results from one of the designated outside laboratories indicating a “rare variant that is an actionable Mutation of Interest (aMOI) for specific designated rare variant subprotocols. See Appendix XIV of the main protocol for a list of the designated laboratories and applicable subprotocols.

The consent form for this sub-study is available upon request when a patient at your site is assigned to the sub-study. Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.

Open to participants with results from one of the designated outside laboratories indicating a “rare variant that is an actionable Mutation of Interest (aMOI) for specific designated rare variant subprotocols. See Appendix XIV of the main protocol for a list of the designated laboratories and applicable subprotocols.

The consent form for this sub-study is available upon request when a patient at your site is assigned to the sub-study. Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.

Open to participants with results from one of the designated outside laboratories indicating a “rare variant that is an actionable Mutation of Interest (aMOI) for specific designated rare variant subprotocols. See Appendix XIV of the main protocol for a list of the designated laboratories and applicable subprotocols.

The consent form for this sub-study is available upon request when a patient at your site is assigned to the sub-study. Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.

Open to participants with results from one of the designated outside laboratories indicating a “rare variant that is an actionable Mutation of Interest (aMOI) for specific designated rare variant subprotocols. See Appendix XIV of the main protocol for a list of the designated laboratories and applicable subprotocols.

The consent form for this sub-study is available upon request when a patient at your site is assigned to the sub-study. Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.

Open to participants with results from one of the designated outside laboratories indicating a “rare variant that is an actionable Mutation of Interest (aMOI) for specific designated rare variant subprotocols. See Appendix XIV of the main protocol for a list of the designated laboratories and applicable subprotocols.

The consent form for this sub-study is available upon request when a patient at your site is assigned to the sub-study. Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.

Open to participants with results from one of the designated outside laboratories indicating a “rare variant that is an actionable Mutation of Interest (aMOI) for specific designated rare variant subprotocols. See Appendix XIV of the main protocol for a list of the designated laboratories and applicable subprotocols.

The consent form for this sub-study is available upon request when a patient at your site is assigned to the sub-study. Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.

Open to participants with results from one of the designated outside laboratories indicating a “rare variant that is an actionable Mutation of Interest (aMOI) for specific designated rare variant subprotocols. See Appendix XIV of the main protocol for a list of the designated laboratories and applicable subprotocols.

The consent form for this sub-study is available upon request when a patient at your site is assigned to the sub-study. Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.

Effective today, January 8th, 2020, EAY131 (MATCH) Subprotocol Z1H-Phase II is suspended and no new patients will be assigned to this treatment arm. Patients who are currently being treated on this subprotocol will continue on the study with no changes in their participation.

Open to participants with results from one of the designated outside laboratories indicating a “rare variant that is an actionable Mutation of Interest (aMOI) for specific designated rare variant subprotocols. See Appendix XIV of the main protocol for a list of the designated laboratories and applicable subprotocols.

The consent form for this sub-study is available upon request when a patient at your site is assigned to the sub-study. Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.

Open to participants with results from one of the designated outside laboratories indicating a “rare variant that is an actionable Mutation of Interest (aMOI) for specific designated rare variant subprotocols. See Appendix XIV of the main protocol for a list of the designated laboratories and applicable subprotocols.

The consent form for this sub-study is available upon request when a patient at your site is assigned to the sub-study. Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.

Please see http://www.swogstat.org/accrual/dart.htm for up-to-date accrual information and current cohort accrual status (i.e. open, closed, suspended). The website is updated with the most current information daily.

The protocol allows designated private sector laboratories to refer patients to the study based on genetic testing performed independent of MATCH. This is limited to genetic testing ordered for patients at approved MATCH trial sites. Approved genetic testing laboratories and their date of inclusion in the outside assay process are:

CARIS Life Sciences – 07/02/18

CellNetix Pathology and Laboratories – 02/13/19

Foundation Medicine – 07/02/18

GenPath BioReference Laboratories – 08/03/18

The Jackson Laboratory – 01/10/19

NeoGenomics Laboratories – 07/02/18

OmniSeq Laboratories – 07/16/18

PathGroup – 10/29/18

Quest Diagnostics Inc. – 05/20/19

Strata Oncology – 08/03/18

Tempus Laboratories – 07/16/18

The Biopsy consent form for this study is available upon request. Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.

The protocol allows designated private sector laboratories to refer patients to the study based on genetic testing performed independent of MATCH. This is limited to genetic testing ordered for patients at approved MATCH trial sites. Approved genetic testing laboratories and their date of inclusion in the outside assay process are:

CARIS Life Sciences – 07/02/18

CellNetix Pathology and Laboratories – 02/13/19

Foundation Medicine – 07/02/18

GenPath BioReference Laboratories – 08/03/18

The Jackson Laboratory – 01/10/19

NeoGenomics Laboratories – 07/02/18

OmniSeq Laboratories – 07/16/18

PathGroup – 10/29/18

Quest Diagnostics Inc. – 05/20/19

Strata Oncology – 08/03/18

Tempus Laboratories – 07/16/18

The Biopsy consent form for this study is available upon request. Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.

Open to participants with results from one of the designated outside laboratories indicating a “rare variant that is an actionable Mutation of Interest (aMOI) for specific designated rare variant subprotocols. See Appendix XIV of the main protocol for a list of the designated laboratories and applicable subprotocols.

The consent form for this sub-study is available upon request when a patient at your site is assigned to the sub-study. Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.

Open to participants with results from one of the designated outside laboratories indicating a “rare variant that is an actionable Mutation of Interest (aMOI) for specific designated rare variant subprotocols. See Appendix XIV of the main protocol for a list of the designated laboratories and applicable subprotocols.

The consent form for this sub-study is available upon request when a patient at your site is assigned to the sub-study. Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.

The accrual goal for the Behaviorial and Health Outcomes (BAHO) Quality of Life component in the B-51 trial has been met. Therefore, effective August 6th, 2018, accrual will be closed to the QoL component. The B-51 trial remains open to accrual.

A Phase II Trial Assessing the Accuracy of Tumor Bed Biopsies in Predicting Pathologic Response in Patients with Clinical/Radiologic Complete Response after Neoadjuvant Chemotherapy in Order to Explore the Feasibility of Breast Conserving Treatment without Surgery

The protocol allows designated private sector laboratories to refer patients to the study based on genetic testing performed independent of MATCH. This is limited to genetic testing ordered for patients at approved MATCH trial sites. Approved genetic testing laboratories and their date of inclusion in the outside assay process are:

CARIS Life Sciences – 07/02/18

CellNetix Pathology and Laboratories – 02/13/19

Foundation Medicine – 07/02/18

GenPath BioReference Laboratories – 08/03/18

The Jackson Laboratory – 01/10/19

NeoGenomics Laboratories – 07/02/18

OmniSeq Laboratories – 07/16/18

PathGroup – 10/29/18

Quest Diagnostics Inc. – 05/20/19

Strata Oncology – 08/03/18

Tempus Laboratories – 07/16/18

The Biopsy consent form for this study is available upon request. Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.

Enrollment is on target to reach the accrual goal necessary to conduct a study-specified planned interim analysis per section 9.4 of the protocol. Only patients who have signed a consent to participate on or before 5:00 PM (EST) June 23rd, and for whom registration is completed by 5:00 PM (EST) June 30th, will be accepted, until further notice.

This protocol has additional training requirements to be completed prior to registering any patients at your site. Please contact Amber Boerner at 406-969-6067 or aboerner@mtcancer.org for additional information.

The protocol allows designated private sector laboratories to refer patients to the study based on genetic testing performed independent of MATCH. This is limited to genetic testing ordered for patients at approved MATCH trial sites. Approved genetic testing laboratories and their date of inclusion in the outside assay process are:

CARIS Life Sciences – 07/02/18

CellNetix Pathology and Laboratories – 02/13/19

Foundation Medicine – 07/02/18

GenPath BioReference Laboratories – 08/03/18

The Jackson Laboratory – 01/10/19

NeoGenomics Laboratories – 07/02/18

OmniSeq Laboratories – 07/16/18

PathGroup – 10/29/18

Quest Diagnostics Inc. – 05/20/19

Strata Oncology – 08/03/18

Tempus Laboratories – 07/16/18

The Biopsy consent form for this study is available upon request. Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.